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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intracardiac mapping, high-density array
510(k) Number K992777
Device Name CONSTELLATION CATHETERS, MODEL 8039
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact STEVE JWANOUSKOS
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact STEVE JWANOUSKOS
Regulation Number870.1220
Classification Product Code
MTD  
Date Received08/18/1999
Decision Date 11/12/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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